Brain-Computer Interface and Mind-Body Awareness Training | NCT02074722

Studies
Brain-Computer Interface and Mind-Body Awareness Training

NCT02074722

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Jan 12, 2018Actual

Enrollment

152Actual

Phase

Not provided

Conditions

Healthy Subjects

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jun 28, 2017Actual

Completion Date

Jun 28, 2017Actual

First Submitted Date

Feb 7, 2014

First Submission Date that Met QC Criteria

Feb 26, 2014

First Posted Date

Feb 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2018

Last Update Posted Date

Jan 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices, has become increasingly prevalent due to an increase in awareness of the potential health benefits, and improvements in concentration that this training can provide to practitioners. In the present study, we investigate the role of Mind-Body Awareness Training (MBAT) in the initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI).

The PI's hypothesis is that MBAT will improve performance in SMR based BCI.

Detailed Description

In this protocol, we will test the PI's hypothesis that MBAT including yoga will improve the ability for subjects to concentrate on control the SMR thus improving the performance of BCI.

Subjects will be recruited for short term MBAT and then undergo BCI training. The performance of subjects with MBAT will be compared with those without MBAT to test the hypothesis. Procedures involved include 6 weeks yoga classes with at least 3 classes per week, and a EEG brain noninvasive brain computer interface study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

152Actual

Label	Type	Description	Intervention Names
Healthy Subjects		Healthy Subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance over BCI sessions	During the course of the study over 5-10 weeks, we will quantitatively examine three main components of data: the proportion of subjects that achieve a pre-determined threshold of one-dimensional BCI competency as a time to event analysis, how subjects performed on average in each metric (accuracy, speed, etc.) over the course of the study (5-10 weeks), and subject learning over time during the course of study (5-10 weeks).	one to three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-64 years old healthy subjects

Exclusion Criteria:

History of traumatic brain injury/brain lesion, history of neurological deficit or neurodegenerative disorder, or history of epileptic seizures.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Healthy population in Minneapolis area

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bin He, PhD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nils Hasselmo Hall at the University of Minnesota - Twin Cities Campus		Minneapolis	Minnesota	55455	United States